Time to Return of Bowel Function Following Perioperative Probiotics in Colorectal Cancer Surgery (PICCS-1)

National University Health System (NUHS)

Status: Enrolling

Conditions: Ileus Postoperative; Flatus; Diet, Healthy; Colorectal Cancer

Treatments: Dietary Supplement: Nestle Isocal; Dietary Supplement: Nestle Boost Optimum

Study type: Interventional

Funder types: Other

Identifiers

NCT06456229

2024/00180

Details and patient eligibility

About

There is pre-existing evidence that probiotics could be useful in the improvement of ileus rates. One metaanalysis of 30 studies demonstrated a reduction in the prevalence of post-operative ileus as determined by time to flatus, time to defecation, as well as postoperative abdominal distension (PMID:37373843). More broadly in gastrointestinal surgery, a meta-analysis of 21 randomised controlled trials similarly affirmed the speedier recovery of gastrointestinal function after surgery when probiotics were administered (PMID: 35231076). In spite of these advantages, the routine use of probiotics perioperatively for colorectal cancer surgery is not performed in Singapore. We therefore seek to perform a trial to investigate whether probiotic administration perioperatively may reduce post operative ileus rates.

Enrollment: 162 estimated patients

Sex: All

Ages: 21 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. undergoing elective colorectal cancer surgery in which an oncologic resection is planned
2. age between 21 and 99 years at the time of consent
3. willing to consider oral nutritional supplementation
4. on an early recovery after surgery (ERAS) pathway
5. able to provide informed consent

Exclusion criteria

1. patients with known contraindications to probiotic use
2. patients undergoing emergency surgery
3. taking any other form of probiotics
4. taking oral antibiotics within 7 days of commencement of study
5. vulnerable patients including pregnant patients, inmates, and those who are cognitively impaired and therefore are not able to provide informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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162 participants in 3 patient groups

Arm 1

No Intervention group

Description:

Control arm with no nutritional supplementation

Arm 2

Active Comparator group

Description:

Control arm with nutritional supplementation but without probiotics

Treatment:

Dietary Supplement: Nestle Isocal

Arm 3

Experimental group

Description:

Nutritional supplementation with probiotics

Treatment:

Dietary Supplement: Nestle Boost Optimum